Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07193862 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
A Early Phase 1 study of Colorectal Cancer Metastatic, sponsored by Northwell Health.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT07193862: Recruiting Early Phase 1 study of Colorectal Cancer Metastatic, sponsored by Northwell Health.
NCT07193862 is a Early Phase 1 study of Colorectal Cancer Metastatic that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 10 participants, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07193862, a Early Phase 1 study of Colorectal Cancer Metastatic, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.
Primary Outcome
To evaluate the safety of microdevice placement and retrieval based on assessment of adverse events. AEs will be defined using Common Terminology Criteria for AEs (CTCAE) v5.0 Any device resulting in either of the following will be considered a failure from a safety standpoint: any listed SAE two or more grade 3-4 AEs directly associated with the device or its placement Significant delay in the standard hepatic resection of more than 14 days due to device-related complications Safety will b
Conditions Studied
Interventions
- COMBINATION_PRODUCT Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373
Study Locations (2)
New York
- RJ Zuckerberg - Lake Success
- Long Island Jewish Medical Center - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-12-10 |
| Est. Completion | 2026-04-15 |
| Phase | Early Phase 1 |
What NCT07193862 shows while recruiting
NCT07193862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Colorectal Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention - of which Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 is the first listed.
NCT07193862 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07193862 about?
NCT07193862 is a clinical study titled "Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis". Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with...
What is the current status of trial NCT07193862?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2025-12-10. Estimated completion is 2026-04-15.
What conditions does trial NCT07193862 study?
This clinical trial studies the following conditions: Colorectal Cancer Metastatic.
What interventions are being tested in trial NCT07193862?
The interventions under investigation include: Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07193862?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07193862 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer Metastatic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07193862's enrollment target sits among peer trials
10 17th of 18 higher than 1 of 18 other Colorectal Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases
RECRUITING · Early Phase 1
-
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
RECRUITING · Phase 2
-
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases
RECRUITING
-
Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection
RECRUITING
-
Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
RECRUITING · Phase 2
-
Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI